FDA Approval Insights: Talquetamab in Relapsed/Refractory Multiple Myeloma


Dr Minnema discusses the FDA approval of talquetamab in patients with relapsed/refractory multiple myeloma, key data from the MonumenTAL-1 trial, and the importance of designing clinical trials to address unmet patient needs.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Monique Minnema, MD, PhD, about the FDA approval of talquetamab-tgvs (Talvey) in patients with relapsed/refractory multiple myeloma. Dr Minnema is a full professor in the Department of Hematology at the University Medical Center Utrecht, Netherlands.

On August 10, 2023, the FDA granted accelerated approval to talquetamab for adult patients with relapsed/refractory multiple myeloma who have received 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. This regulatory decision was backed by findings from the phase 2 MonumenTAL-1 trial (NCT04634552), in which the overall response rate in patients who were not previously exposed to T-cell redirection therapy who received talquetamab biweekly at 0.8 mg/kg was 73.6% (95% CI, 63.0%-82.4%).

Additionally, on August 22, 2023, the European Commission granted conditional marketing authorization to talquetamab for patients with relapsed/refractory disease who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and whose disease has progressed on the last line of therapy.

In our exclusive interview, Dr Minnema discussed the significance of these approvals, key data from MonumenTAL-1, and the importance of designing clinical trials to address unmet patient needs.


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